BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10843982 · Received November 16, 2020

    Report

    Report Number
    1000432246-2020-00010
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    July 1, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDN
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    UNID RODS WERE IMPLANTED ON (B)(6) 2020, THE PATIENT REQUIRED SURGERY BECAUSE OF A SACRAL FRACTURE/SACRAL HEMANGIOMA. RIGHT UNID ROD BROKE IN (B)(6) 2020, BELOW S5 SCREW. PATIENT STATED PAIN, WEAKNESS, AND NUMBNESS DOWN THE LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311927 PASS LP UNID COCR 5.5MM - QTY 2 JDN MEDICREA INTERNATIONAL B33225512-02 0W1TX5ZJ

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention